Actively Recruiting
Online Problem-Solving Intervention for Brain Tumor Survivors: A Two-site, Two-arm Pilot Randomized Controlled Trial
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-07
72
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
Nationwide Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an online program called Survivors Journey Plus (SJ+) designed to help teens and young adults aged 15 to 25 who have survived pediatric brain tumors, along with their caregivers. The study aims to see if SJ+ is feasible and acceptable, and whether it improves wellbeing compared to an internet resource comparison (IRC). The trial focuses on quality of life, internalizing symptoms, executive function skills, depression, and family impact in this group. Participants are randomly assigned to one of two groups: one receives access to the SJ+ program with weekly online coaching sessions, and the other gets access to an internet resource comparison website with pediatric brain tumor survivor information but no session content. The intervention offers training in problem-solving, stress management, metacognitive and communication skills tailored to address challenges faced by brain tumor survivors and their families. Outcomes are assessed at the start, about three months after baseline when treatment ends, and again six months after baseline. During the study, participants and caregivers complete evaluations including quality of life surveys, measures of executive function, anxiety, depression, and family impact at specified time points. Researchers track changes from baseline to six months post-baseline to assess the program's effects. The total study duration for each participant is approximately six months, with monitoring of participant wellbeing and program acceptability throughout this period.
CONDITIONS
Brief Title
Survivors Journey+
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A diagnosis of a pediatric intracranial tumor
- Tumor-directed treatment completed more than 12 months ago (including surgery, radiation, or chemotherapy)
- Lives with parent or guardian(s)
- English is the primary spoken language in the home
You will not qualify if you...
- History of tuberous sclerosis or neurofibromatosis
- Treatment less than 12 months ago or treatment did not include surgery, radiation, or chemotherapy
- History of psychiatric hospitalization
- Resides outside of the family home
- History of autism, reactive attachment disorder, psychosis, or other psychiatric diagnoses with significant risk of harm to self or others as reported by caregiver
- English is not the primary language spoken in the home
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 months
Participants engage in a family-centered, online behavioral intervention focusing on stress management, problem-solving, metacognitive strategies, self-regulation, and communication skills tailored for pediatric brain tumor survivors and their caregivers.
1 baseline visit and 1 follow-up visit at treatment completion
Duration - Up to 3 months after treatment completion (6 months post-baseline)
Participants are monitored to assess lasting effects on quality of life, executive functioning, and caregiver well-being after completing the intervention.
1 follow-up visit at 6 months post-baseline
Trial Site Locations
Total: 2 locations
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
2
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
S
Shari L Wade, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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